Kornimate/medical-research-clean huggingface dataset:
the pharmacokinetics of grazoprevir (mk-5172) and elbasvir (mk-8742) in participants with renal insufficiency (mk-5172-050)

Conditions: Chronic Hepatitis C; Renal Impairment

Summary: grazoprevir (mk-5172) and elbasvir (mk-8742) were studied as the principal components of combination oral therapy for hepatitis c virus (hcv). the study examined the pharmacokinetic (pk) profiles of grazoprevir and elbasvir following 10 days of dosing in participants with end stage renal disease (esrd) on hemodialysis (hd) or participants with severe renal impairment. both groups were compared to healthy matched controls.


Eligibility criteria:
inclusion criteria: all participants * for a female of childbearing potential: either be sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or be using an acceptable birth control method. females of non-childbearing potential must have undergone a sterilization procedure at least 6 months prior to the first dose * non-vasectomized male participants must agree to use a condom with spermicide or abstain from sexual intercourse during the trial and for 90 days after stopping the study medication and agree not to donate sperm during this time period participants with esrd on hd * maintained on a stable regimen of hd within 3 months prior to first dosing participants with severe renal impairment * estimated glomerular filtration rate (egfr) at screening is \< 30 ml/min/1.73m\^2 healthy controls * participant is within ± 10 years of the mean age and within 10% of the mean body mass index of severe renal impairment participants * egfr at screening is \>=80 ml/min/1.73m\^2 exclusion criteria: all participants * history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease whose current condition is considered unstable * history or presence of alcoholism and drug abuse within the past 6 months * female participants who are pregnant or lactating * regular user of any medication (including over the counter) that would significantly alter gfr * donation of blood or significant blood loss within 56 days prior to the first dose of study medication(s) * plasma donation within 7 days prior to the first dose of study medication(s) * a renal transplant or nephrectomy participants with esrd or severe renal impairment * rapidly fluctuating renal function
correlation of eicosanoid and proresolving lipid mediator temporal profiles and resolution of pain after thoracic surgery

Conditions: Pain, Postoperative

Summary: the aim of the current pilot study is to investigate whether perioperative dysregulated systemic lipid mediator pathways (more specifically increased pro-inflammatory and decreased anti-inflammatory pathways) are associated with slower resolution of pain after surgery and increased risk for development of persistent postsurgical pain (ppsp). in addition, we will look for correlations between the pro-resolving lipid mediator profile and quality of recovery (qor-15), duration of hospital stay, and frequency of complications, e.g. wound infections.

this is a prospective, observational pilot study that will assess whether 1) a peri-operative dysregulated metabolo-lipidomics or spm profile is associated with slower resolution of pain after surgery and an increased risk for development of persistent postsurgical pain (ppsp), and 2) whether a peri-operative dysregulated metabolo-lipidomics profile correlates with low quality of recovery (qor-15) scores, duration of hospital stay and frequency of complications, e.g. wound infection. the study will address the following specific aims: specific aim 1: to determine the correlation between the perioperative eicosanoid and pro-resolving lipid mediator temporal profile and day-to-day resolution of pain after thoracic surgery. we hypothesize that patients who have slower resolution of pain after thoracic surgery have dysregulated systemic lipid mediator pathways when compared to those patients who have faster resolution of pain. specific aim 2: to determine the effectiveness of perioperative spm signature as a novel predictive marker for the development of persistent pain after surgery (ppsp). we hypothesize that patients with dysregulated systemic lipid mediator pathways, more specifically up-regulated pro-inflammatory lipid mediator pathways and down-regulated pro-resolving lipid mediator pathways, are more likely to develop ppsp. specific aim 3: to determine the correlation between the perioperative eicosanoid and pro-resolving lipid mediator temporal profile and quality of recovery after surgery, duration of hospital stay and complications. we hypothesize that dysregulated lipid mediator profiles are associated with a decreased quality of recovery score (qor-15), prolonged hospital stay and increased rates of complications, such as problems with wound healing and infection.

Eligibility criteria:
inclusion criteria: * age 18-85 * patients scheduled to undergo thoracic surgery at brigham and women's hospital exclusion criteria: * pre-existing chronic pain or opioid use * current treatment with corticosteroids * evidence of active infection * chronic liver disease, end-stage renal disease (ckd-5), or chronic inflammatory disorders * recent major surgery or illness within 30 days * use of immunosuppressive medication * history of organ transplantation.
improved immunology outcomes associated with lactoferrin fortified with hmo in infant formula

Conditions: Flu; Cold

Summary: the goal of this interventional clinical trial is to test the effectiveness of enhancing immunity in newly born infants fed with feihe investigational formula product containing lactoferrin fortified with hmo. the main question it aims to answer is: - whether the immunity functions of participants in terms of frequency of catching flu and cold in the study product arm is significantly better than participants assigned in the other two arms. 240 qualified participants will be randomized to 3 arms (investigational formula, control formula, and breast-feeding) to consume assigned formula or breast-feeding for 12 months according to protocol. there will be up to 6 site visits arranged for each participant during the study, and all relevant clinical and questionnaire data, including the most important primary outcome - frequency of catching flu and cold for each visit interval, will be captured, recorded and entered to cmts (clinical management trial system) for statistical analysis and reporting. researchers will compare the three arms to validate the assumption that the consumption of feihe investigational formula product containing lactoferrin fortified with hmo will improve immunity in newly born infants, along with physical development.


Eligibility criteria:
inclusion criteria: * newborn baby, study entry before weaning (within 28 days of birth) * exclusively formula for at least 3 days fed prior to onset of study period. * gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks gestational age). * birth weight of 2500g (5 lbs. 8 oz.) or more. * signed informed consent obtained for infant's participation in the study. * parent or guardian of the infant agrees to not enroll the infant in another interventional clinical research study while participating in this study. exclusion criteria: * history of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant. * evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake, at time of randomization (at investigator discretion). * evidence of growth problems or concern for growth. * infant was born large for gestational age (lga) (defined as birth weight-for-age exceeding 90th percentile as plotted on the growth chart provided by feihe) from mother who was diabetic at childbirth. * participant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as combined immunodeficiencies, digeorge syndrome, wiskott-aldrich syndrome, severe congenital neutropenia and secondary immunodeficiencies linked to hiv infection, down syndrome or others) and children with known head/brain disease/injury. * use of probiotics/prebiotics before and during the study.

Keywords: infant formula lactoferrin hmo (human milk oligosaccharides) immunology
delivery optimization for pre-exposure prophylaxis (do prep) study

Conditions: HIV; Human Immunodeficiency Virus; ART

Summary: the overall goal is to determine whether an end-to-end decentralized delivery service for prep is more effective, safe, acceptable, and cost-effective than facility-based prep delivery.

optimizing pre-exposure prophylaxis (prep) delivery with a focus on priority populations is critical to realize the enormous potential of prep for hiv prevention. hiv incidence remains relentlessly high among young women and sexual minority men and primary prevention is critical to achieving control of the hiv epidemic. with effective and persistent use, oral pre-exposure prophylaxis (prep) for hiv prevents 75%-100% of hiv cases among cisgender women and men, gay and bisexual men, and transgender women. despite the high efficacy, uptake throughout the prep prevention cascade remains low. south africa is expanding prep provision but requires evidence-based strategies on how to achieve access, effective use, and persistence. the current clinic-based requirement of prep to persons at risk for hiv acquisition requires that clients self-identify their exposure to hiv and visit the clinic regularly for initiation, monitoring and refills. barriers to prep access include clinic level factors (i.e. staff training, brief visits) and individual level factors including logistics such as transportation for clinic visits. the priority is to determine how to deliver prep in a scalable way and achieve high prep access and effective, persistent use. prep is a highly efficacious hiv prevention strategy but requires effective strategies that streamline delivery and engage users for scale-up. community-based strategies for hiv testing, art initiation, and monitoring successfully reach people living with hiv for treatment and have made marked improvements to viral suppression. this protocol describes a randomized clinical study to test an end-to-end decentralized delivery service for prep. it aims to safely increase prep access and use among priority populations in south africa. participants will include 16-30 year old hiv negative women and sexual minority men at high risk for acquiring hiv. as a critical component of decentralized delivery, we will also evaluate the safety and efficacy of hiv self-testing compared to rapid diagnostic tests.

Eligibility criteria:
inclusion criteria: * aged 16 years - 30 years old, * men in serodifferent relationships or those reporting male to male sex, * heterosexual cis-gender females * interested in use of prep for hiv prevention * able and willing to provide informed consent for study procedures exclusion criteria: * hiv infection based on negative hiv rapid tests * clinically ineligible for prep * the participant doesn't reside in the study community for the duration of follow-up
a study of edg-7500 in adults with hypertrophic cardiomyopathy (cirrus-hcm)

Conditions: Hypertrophic Cardiomyopathy

Summary: this study is being conducted in order to understand the safety and effects of different doses of edg-7500 as a single dose in adults with obstructive hypertrophic cardiomyopathy (ohcm) and as multiple doses in adults with obstructive or nonobstructive hypertrophic cardiomyopathy (nhcm).


Eligibility criteria:
key inclusion criteria: * male or nonpregnant female, age ≥18 years. * body mass index (bmi) ≥18 to \<38 kg/m2; weight ≥50 kg at screening. * diagnosed with hypertrophic cardiomyopathy at the time of screening consistent with current american college of cardiology foundation/american heart association guidelines * lvot peak gradient ≥30 mmhg measured at rest and ≥50 mmhg post-valsalva as determined by echocardiography at screening (part a, b and d ohcm only). * lvot peak gradient \< 30 mmhg measured at rest and \< 50 mmhg measured during the valsalva maneuver as determined by echocardiography as assessed by the investigator at screening (part c and d nhcm only). * maximal exercise peak lvot gradient \< 50 mmhg as determined by echocardiography as assessed by the investigator (historical documentation \< 12 months prior to dosing or confirmed at screening) (part c and d nhcm only). * documented left ventricular ejection fraction (lvef) ≥0.60 at screening. * new york heart association (nyha) classification i-iii at screening. key exclusion criteria: * invasive septal reduction \<180 days prior to screening. * documented current or history of obstructive coronary artery disease at any time or myocardial infarction \<180 days prior to screening. * known stage b or higher aortic valve stenosis or regurgitation * documented current or history of cardiac amyloidosis (age ≥ 60 years requires exclusion of cardiac amyloidosis by radionuclide scan or mri performed at screening or historical scan \<3 years prior to screening). * a history of syncope or sustained ventricular tachyarrhythmia \<180 days prior to screening. * a history of sudden cardiac arrest at any time or known appropriate implantable cardioverter defibrillator (icd) discharge \<180 days prior to screening * atrial fibrillation (af) at screening; a current diagnosis of permanent af; paroxysmal or persistent af \<90 days of screening, or electrical cardioversion or ablation for af \<90 days of screening. * fridericia-corrected qt interval (qtcf) ≥480 ms or any other ecg abnormality considered by the investigator to pose a risk to participant safety. * current or prior use of any cardiac myosin inhibitors * a history of diabetes with a hemoglobin a1c ≥ 7.5% at the screening visit (part c and d nhcm only)
intraoperative methadone for postoperative pain control

Conditions: Bariatric Surgery Candidate

Summary: to compare patient pain perception and satisfaction as well as opioid-related side effects during inpatient and outpatient care when undergoing bariatric enhanced recovery after surgery protocols with and without methadone.


Eligibility criteria:
inclusion criteria: • all patients undergoing initial gastric sleeve resection exclusion criteria: * age \ 60 years * patients with bmi \>60 * ahi \> 30 (ahi = apnea-hypopnea index), indicative of severe obstructive sleep apnea (osa) * asa iv or v (american society of anesthesiology physical status classification system) * patients taking opioids for chronic conditions in the last 10 days preceding the surgery * patients currently being treated for chronic opioid addiction * patients with severe psychiatric diagnoses * allergies to medications used in protocol

Keywords: methadone bariatric surgery pain management
accuracy of non-invasive temperature measurement in deep hypothermia

Conditions: Hypothermia

Summary: in pre-hospital care, there are few non-invasive thermometers that are proved both robust and accurate. the aim of this study is to investigate the accuracy of a certain ear-canal based thermometer on patients undergoing thoracic surgery in deep hypothermia.

the study is a prospective cohort study on patients undergoing elective thoracic surgery in deep hypothermia. the goal is to assess the accuracy of non-invasive temperature devices compared to a gold standard representing core temperature. at the study hospital, oslo university hospital rikshospitalet, patients undergoing thoracic surgery will already have several routes of temperature monitoring as part of standard procedure. before cardiopulmonary bypass bladder temperature is normally used as a reference for core temperature. after cardiopulmonary bypass is established, temperature is monitored directly in the circulating blood, hence reflecting core temperature. for measuring the epitympanic temperature we will use the metraux epitympanic thermometer (walpoth, galdikas et al. 1994), a nasopharyngeal temperature probe (mon-a-therm, general purpose temperature probe 12fr/ch, covidien) and a new transcutaneous device (spoton 3m). the temperature will be measured in degrees celsius. the first reading will be noted just after induction of anaesthesia and compared to the bladder temperature. after cardiopulmonary bypass (cpb) is established and therapeutic hypothermia is induced, the values for both non-invasive and blood temperature will be recorded every minute. after reaching the target temperature according to the blood temperature, we will continue recording the non-invasive temperature until relative similarity is established. the process will be repeated during re-warming.

Eligibility criteria:
inclusion criteria: * adult \>18 years * elektive cardiac surgery in deep hypothermia * no pathology in ear canal on otoscopy exclusion criteria: * pathology in ear canal * non-consent

Keywords: hypothermia temperature epitympanic pre-hospital
effectiveness of standing frame on constipation in children with cerebral palsy

Conditions: Cerebral Palsy; Quadriplegia; Diplegia; Constipation

Summary: children with cerebral palsy and quadriplegia or severe diplegia suffer from highly reduced mobility and consequent constipation. clinicians frequently recommend standing-frames to exercise the support reaction in this population, sharing the opinion that the upright position may facilitate intestinal transit, although no evidence supports this assumption. the investigators conducted this single-subject research to determine the effects of the standing-frame on the frequency of evacuation in chronically constipated children with cp and quadriplegia. moreover, the investigators studied its effects on the frequency of induction of evacuation, the characteristics of the stool and the pain suffered by the child due to constipation and/or evacuation.


Eligibility criteria:
inclusion criteria were: * clinical indication for the use of the standing-frame; * constipation problems as defined by guidelines (clinical practice guideline, 2006); * whose parents gave the informed consent to let their child to participate in this study. exclusion criteria were: * children who have orthosympathetic reactions to the upright position, skeletal deformities and/or medical conditions that, according to clinical judgment, advise against the use of the standing frame.

Keywords: standing-frame chronic constipation cerebral palsy quadriplegia severe diplegia
muscle vibration and joint position sense

Conditions: Vibration; Exposure

Summary: the present study aimed to investigate and compare the acute effect of local vibration (63 hz vs 42 hz frequencies) on the biceps brachii muscles on the elbow joint position sense (jps) in healthy young men. forty-five healthy young men aged 19 to 30 years were enrolled in the study. the participants were randomly assigned to receive either 63 hz (n=15) or 42 hz (n=15) or sham vibration (control group) (n=15). participants in the experimental group received five bouts of 1-minute of each vibration exposure localized to the biceps brachii muscle, with a 1-minute rest between the bouts. active elbow joint position error (in degrees) was selected as an outcome measure to assess elbow jps. to measure active elbow joint position error, the subject was made to sit on the chair with eyes closed and shoulders in 0 degree of abduction and elbows fully extended. the examiner passively moved the elbow to 90 degrees of flexion (target position) and maintained it for 10 seconds. the subject was requested to memorize the target position. the subject was asked to actively flex the elbow to the target position from the initial starting position (elbow fully extended) and hold it for 5 seconds. three trials were conducted, with a 30-second rest given between each trial. the target and reproduced angles in each trial were measured using a standard plastic goniometer. the difference between the target and reproduced angles in each trial was calculated to determine active elbow joint position error. measurements were taken at baseline and immediately after the vibration protocol.


Eligibility criteria:
inclusion criteria: * healthy young men exclusion criteria: * history of recent upper extremity surgery * history of sensory deficits in the upper extremity * recent upper extremity injury * undergoing any resistance training

Keywords: muscle vibration joint position sense proprioception elbow rehabilitation
intensive longitudinal assessment of stress and stress-related concepts across a behavioral weight loss intervention

Conditions: Individual Stress and Weight Loss

Summary: examine the association between variability in individual stress and related concepts with weight loss, physical activity, and sleep across a behavioral weight loss program


Eligibility criteria:
inclusion criteria: * enrolled in a kumc community-based weight loss program centered in a metropolitan area of a midwest state. based on this criteria, we will anticipate participants are greater than 18 years of age, and have obesity * must own a smart phone and be willing to download the mobile application to receive text messages exclusion criteria: * report a current medical condition or treatment for a medical condition that could affect body weight. * current psychological condition that is untreated, hospitalization for a psychological condition within the past 12 months, or not being on a stable dose of treatment for at least 6 months. * clinically diagnosed depression. * is not fluent in writing or speaking the english language. * mobility limitations so they are unable to perform physical activity. * family member currently enrolled in the study or has a family member that previously participated in the study.

Keywords: stress weight loss ema weight gain cortisol surveys
tocilizumab for prevention of respiratory failure in patients with severe covid-19 infection

Conditions: COVID-19

Summary: the purpose of this study is to find out whether the study drug tocilizumab is an effective treatment for covid-19 infection.


Eligibility criteria:
inclusion criteria: * patient or designated proxy willing and able to provide informed consent prior to enrollment in the study. * covid-19 pcr positive on nasopharyngeal swab * aged \>/= 18 years old * patient hospitalized with newly diagnosed documented severe covid-19 infection: with respiratory rate \>/= 30 breaths/min or peripheral capillary oxygen saturation (spo2) \< 93% on room air for nonintubated pts. * fever of 38.5 c or suspected respiratory infection * il-6 level \>/= 80 pcg/ml * cohort #1 - non intubated cohort #2 - intubated * women of childbearing potential must have a negative serum or urine pregnancy test * patients receiving ongoing steroid therapy are eligible * patients will be allowed to receive concurrent or sequential treatment with remdesivir exclusion criteria: * patients with uncontrolled systemic fungal and bacterial infections * patients with latent tuberculosis * patients with known hypersensitivity to tocilizumab or any component of the formulation * concurrent initiation of steroid therapy is not allowed * patients with uncrontroled malignant disease, with a life expectancy of 3 months or less

Keywords: covd-19 tocilizumab respiratory infection 20-185 memorial sloan kettering cancer center